O'Brien Kate M, Wiggers John, Williams Amanda, Campbell Elizabeth, Wolfenden Luke, Yoong Serene, Robson Emma K, McAuley James, Haskins Robin, Kamper Steven J, Williams Christopher
Hunter New England Population Health, Wallsend, New South Wales, Australia Hunter Medical Research Institute, Newcastle, New South Wales, Australia University of Newcastle, Newcastle, New South Wales, Australia.
Hunter New England Population Health, Wallsend, New South Wales, Australia.
BMJ Open. 2016 Mar 3;6(3):e010203. doi: 10.1136/bmjopen-2015-010203.
INTRODUCTION: Knee osteoarthritis (OA) is one of the most common chronic diseases worldwide and is associated with significant pain and disability. Clinical practice guidelines consistently recommend weight management as a core aspect of care for overweight and obese patients with knee OA; however, provision of such care is suboptimal. Telephone-based interventions offer a novel approach to delivery of weight management care in these patients. The aim of the proposed study is to assess the effectiveness of referral to a telephone-based weight management and healthy lifestyle programme, previously shown to be effective in changing weight, in improving knee pain intensity in overweight or obese patients with knee OA, compared to usual care. METHODS AND ANALYSIS: A parallel, randomised controlled trial will be undertaken. Patients with OA of the knee who are waiting for an outpatient orthopaedic consultation at a tertiary referral public hospital within New South Wales, Australia, will be allocated to either an intervention or a control group (1:1 ratio). After baseline data collection, patients in the intervention group will receive a 6-month telephone-based intervention, and patients in the control group will continue with usual care. Surveys will be conducted at baseline, 6 and 26 weeks post-randomisation. The study requires 60 participants per group to detect a two-point difference in pain intensity (primary outcome) 26 weeks after baseline. ETHICS AND DISSEMINATION: The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015-0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12615000490572, Pre-results.
引言:膝关节骨关节炎(OA)是全球最常见的慢性病之一,会导致严重疼痛和功能障碍。临床实践指南一直建议将体重管理作为超重和肥胖膝关节OA患者护理的核心内容;然而,此类护理的提供情况并不理想。基于电话的干预措施为这些患者提供体重管理护理提供了一种新方法。本研究的目的是评估转诊至一个基于电话的体重管理和健康生活方式项目(该项目先前已证明在改变体重方面有效)与常规护理相比,对改善超重或肥胖膝关节OA患者膝关节疼痛强度的有效性。 方法与分析:将进行一项平行随机对照试验。在澳大利亚新南威尔士州一家三级转诊公立医院等待门诊骨科会诊的膝关节OA患者将被分配至干预组或对照组(1:1比例)。在收集基线数据后,干预组患者将接受为期6个月的基于电话的干预,对照组患者将继续接受常规护理。在随机分组后的基线、6周和26周进行调查。该研究每组需要60名参与者,以检测基线后26周疼痛强度(主要结局)的两点差异。 伦理与传播:该研究已获得亨特新英格兰卫生人类研究伦理委员会(13/12/11/5.18)和纽卡斯尔大学人类研究伦理委员会(H - 2015 - 0043)的批准。研究结果将在同行评审期刊和科学会议上发表。 试验注册号:ACTRN12615000490572,预结果。
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